Common use of FDA Audit Clause in Contracts

FDA Audit. Upon the request of the FDA or any other Governmental Authority, such agency shall be granted access to observe and inspect each Party’s facilities and/or the procedures used in the manufacturing or warehousing of Product and to audit such facilities and such procedures for compliance with current good manufacturing practices and/or other Applicable Laws. The Party being audited shall provide notice to the other Party. The audited Party shall provide a reasonable written description of any such governmental inquiries, notifications or inspections within two (2) days after such visit or inquiry; provided, that the audited Party shall also furnish to the other Party (a) any report or correspondence issued by the FDA or other Governmental Authority in connection with such visit or inquiry, including any FDA Form 483 (List of Inspectional Observations) or applicable portions of any FDA Warning Letters which pertain to Product in the Territory and (b) in accordance with above, copies of proposed responses or explanations relating to items set forth above, in each case redacted of trade secrets or other Confidential Information of such Party or its Affiliates that are unrelated to its obligations under this Agreement or are unrelated to Product. After the filing of a response with the FDA or other Governmental Authority, the filing Party will promptly notify the other Party of any further contacts with such agency relating to the subject matter of the response.